FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose
LONDON, April 30, 2021 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration (FDA) for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 30, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
LAUSANNE, Switzerland--(BUSINESS WIRE) APRIL 23, 2021 -- ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynlonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 23, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer
London UK 22 April 2021 -- GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company’s Biologics... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 22, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves ALK's Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis
ROUND ROCK, Texas, April 19, 2021 /PRNewswire/ -- ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 19, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opdivo (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma Regardless of PD-L1 Expression Status
PRINCETON, N.J.--(BUSINESS WIRE)-- April 16, 2021 Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall survival versus chemotherapy alone in a trial of this patient population1 U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control
15 April 2021, Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 15, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Grants Accelerated Approval to Trodelvy for the Treatment of Metastatic Urothelial Cancer
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 13, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 13, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications
South San Francisco, CA -- April 12, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 12, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Trodelvy, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Qelbree (viloxazine) for the Treatment of ADHD
ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 2, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sarclisa (isatuximab-irfc) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma
PARIS, March 31, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 31, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia
Morristown, N.J. March 31, 2021 -- Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 31, 2021 Category: Drugs & Pharmacology Source Type: news

Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients
DUBLIN, March 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 30, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Indication & New Product Formulation for Myrbetriq for Use in Children with Neurogenic Detrusor Overactivity (NDO)
TOKYO, March 26, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq (mirabegron extended-release tablets)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Abecma (idecabtagene vicleucel) as the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
PRINCETON, N.J.,& CAMBRIDGE, Mass.--(BUSINESS WIRE) March 26, 2021 -- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma
KENILWORTH, N.J.--(BUSINESS WIRE) March 23, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 23, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Zegalogue (dasiglucagon) Injection for the Treatment of Severe Hypoglycemia in People with Diabetes
Copenhagen, DK and Boston, MA, U.S. March 22, 2021– Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ponvory (ponesimod) for the Treatment of Adults with Relapsing Multiple Sclerosis
TITUSVILLE, N.J.– (March 19, 2021)– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) approved Ponvory™ (ponesimod), a once-daily oral selective... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2021 Category: Drugs & Pharmacology Source Type: news

Kiniksa Announces FDA Approval of Arcalyst (rilonacept) for Recurrent Pericarditis
HAMILTON, Bermuda, March 18, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 18, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kimyrsa (oritavancin) for the Treatment of Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
MORRISTOWN, N.J., March 15, 2021 (GLOBE NEWSWIRE)— Melinta Therapeutics, LLC (Melinta), a commercial-stage company focused on the development and commercialization of novel antibiotics, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 15, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma
BOSTON--(BUSINESS WIRE) March 10, 2021 -- AVEO Oncology (Nasdaq: AVEO) today announced that the U.S. Food and Drug Administration (FDA) has approved Fotivda (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 10, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Yescarta for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy
SANTA MONICA, Calif.--(BUSINESS WIRE)--Mar. 5, 2021-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta® (axicabtagene... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Expands Approval of Pfizer ’s Lorbrena as First-Line Treatment for ALK-Positive Metastatic Lung Cancer
NEW YORK--(BUSINESS WIRE) March 03, 2021 -- The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for Lorbrena® (lorlatinib), expanding the indication to include first-line... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 3, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Azstarys (serdexmethylphenidate and dexmethylphenidate) Capsules for the Once-Daily Treatment for ADHD
CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 2, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nulibry (fosdenopterin) to Reduce the Risk of Mortality in Patients with Molybdenum Cofactor Deficiency (MoCD) Type A
PALO ALTO, February 28, 2021– BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and affiliate Origin Biosciences, Inc. (Origin) today announced the U.S. Food and Drug Administration (FDA) has approved Nulibry (fosdenopterin) for Injection as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 28, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Pepaxto (melphalan flufenamide) for Patients with Relapsed or Refractory Multiple Myeloma
STOCKHOLM, Feb. 26, 2021 /PRNewswire/ -- Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Amondys 45 (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45
CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Amondys 45... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 25, 2021 Category: Drugs & Pharmacology Source Type: news

Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis
NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 24, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Libtayo (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-Small Cell Lung Cancer with PD-L1 Expression of ≥50%
TARRYTOWN, N.Y. and PARIS, Feb. 22, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 22, 2021 Category: Drugs & Pharmacology Source Type: news

Entresto Granted Expanded Indication in Chronic Heart Failure by FDA
EAST HANOVER, N.J., Feb. 16, 2021 -- Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression
RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Cosela (trilaciclib) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 12, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Evkeeza (evinacumab-dgnb) for Patients with Homozygous Familial Hypercholesterolemia
TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) approved Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 11, 2021 Category: Drugs & Pharmacology Source Type: news

Botox (onabotulinumtoxinA) Receives FDA Approval for Pediatric Detrusor Overactivity Associated with a Neurologic Condition
NORTH CHICAGO, Ill., Feb. 10, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved Botox® for the treatment of detrusor (bladder muscle) overactivity... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 10, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Libtayo (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, Feb. 9, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 9, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Breyanzi (lisocabtagene maraleucel) CAR-T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma
PRINCETON, N.J.--(BUSINESS WIRE) February 5, 2021 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 5, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ukoniq (umbralisib) for Marginal Zone Lymphoma and Follicular Lymphoma
NEW YORK, Feb. 05, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (FDA) has approved Ukoniq™ (umbralisib), for the treatment of adult patients with relapsed or refractory... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 5, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tepmetko (tepotinib) as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations
ROCKLAND, Mass., Feb. 3, 2021 /PRNewswire/ -- EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has approved Tepmetko® (tepotinib)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 3, 2021 Category: Drugs & Pharmacology Source Type: news

BioCryst Announces FDA Approval of Supplemental New Drug Application for Rapivab Expanding Patient Population to Include Children Six Months and Older
RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for Rapivab®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 3, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Posimir (bupivacaine) for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression
CUPERTINO, Calif., Feb. 2, 2021 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Posimir (bupivacaine solution) for infiltration use in adults for administration into the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 2, 2021 Category: Drugs & Pharmacology Source Type: news

Biogen Announces FDA Approval of Plegridy (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis
CAMBRIDGE, Mass., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy® (peginterferon... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 1, 2021 Category: Drugs & Pharmacology Source Type: news

Adamas Announces FDA Approval for Second Indication for Gocovri as an Adjunctive Treatment to levodopa/carbidopa in Parkinson ’s Disease Patients Experiencing OFF Episodes
EMERYVILLE, Calif.--(BUSINESS WIRE)--Feb. 1, 2021-- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 1, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis
VICTORIA, British Columbia& ROCKVILLE, Md.-- January 22, 2021 -- Aurinia Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lupkynis (voclosporin) in combination with a background... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Approves Opdivo (nivolumab) in Combination with Cabometyx (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma
PRINCETON, N.J.--(BUSINESS WIRE) January 22, 2021-- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment
London, 21 January 2021 – ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 21, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Verquvo, a soluble guanylate cyclase (sGC) stimulator, to reduce... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 20, 2021 Category: Drugs & Pharmacology Source Type: news

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 15, 2021 (HORSHAM, Pa.)– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj), a subcutaneous... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 15, 2021 Category: Drugs & Pharmacology Source Type: news

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer
TOKYO& MUNICH& BASKING RIDGE, N.J.--(BUSINESS WIRE) January 15, 2021 -- Daiichi Sankyo Company, Ltd.  (hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 15, 2021 Category: Drugs & Pharmacology Source Type: news

Pfizer ’s Xalkori (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults
NEW YORK--(BUSINESS WIRE) January 14, 2021 -- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Xalkori® (crizotinib) for the treatment of pediatric... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 14, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB)
IRVINE, Calif.& BASEL, Switzerland--(BUSINESS WIRE)--Dec. 23, 2020-- Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kineret (anakinra) for the Treatment of Deficiency of IL-1 Receptor Antagonist (DIRA)
WALTHAM, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Sobi™, an international biopharmaceutical company dedicated to rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2020 Category: Drugs & Pharmacology Source Type: news